BEUDAMED
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    LDR SPINE USA AVENUE L INTERBODY FUSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636133·CoRoent Ant TLIF PEEK, 11x13x28mm 15°

    AOS TIBIAL NAIL 13mm x 28.5cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016413·

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104486·Rod Straight 5.5 x 85mm

    RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIXTAL DZ-4100 SERIES PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·February 8, 2007

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013

    UNKNOWN DEPUY 28MM HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 20, 2011

    M SERIES HEATED HUMIDIFIER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BTT·August 8, 2008

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025